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Ortolan Group
,
Basildon, Essex
Regulatory Affairs Compliance Manager
Overview
Job Description
Regulatory Affairs Compliance Manager Basildon, full-time permanent position. Atnahs has an opportunity for a highly motivated and strategic regulatory professional to join our growing organization and help to establish a new regulatory compliance team. This is a new role within the team where you will be working closely with our QA, Technical Operations and other regulatory experts to ensure regulatory compliance of third-party manufacturers. Atnahs is a fast-growing pharmaceutical company with a portfolio of over 20 brands across 140 markets. Our team of over 90 employees are based across our offices in Basildon (UK), Copenhagen (Denmark) and Vadodara (India). We acquire, develop and market a portfolio of mature branded medicines globally: Acquire We acquire "mature" (i.e. post-patent expiry), established branded prescription medicines from large cap and specialty pharma. Develop We develop line extensions (new formulations or new markets) to the medicines we acquire. We also develop our own niche generic medicines in-house. Market We currently own and market a portfolio of more than 20 medicines and operate in more than 140 markets globally. The role Reporting to Head of Regulatory Affairs your main responsibility will be to support compliance at our manufacturing facility in the validation and production of licenced products and to support all our regulatory actives. Other responsibilities will include. * Providing regulatory compliance support to 3rd party manufacturing sites. * Reviewing and approving master manufacturing documentation. * Designing process validation strategy and review of protocols. * Supporting the Technical Operations department in overseeing all process validations of 3rd party manufactured and licenced products, providing timely review and approval as necessary. * Working with the regulatory strategist to define the necessary licence variations ahead of the validation plan. * Timely and accurate reviewing master production records testing specifications and analytical methodology in accordance with the registered details. and completed batch records for validation batches from 3rd party manufacturers required for technical transfer related submissions. * Communicating compliance issues and mitigation plans relating to 3rd party manufacturers to all relevant departments. * Co-ordinating activities of the of the regulatory compliance group to ensure adequate and timely support to our regional markets. * Maintenance and approval of master manufacturing documentation, testing specifications and analytical methodology from 3rd party manufacturers. * Supporting the maintenance and authoring of internal documentation summarising the key licencing details, Master Production Specifications (MPS). * Reviewing supply chain maps to ensure these align with the registered sites of activities. Person Specification We are looking for an experienced regulatory professional with at least 10 years experience for this role with compliance experienced gained within another pharmaceutical company, CRO, CMO or similar organisation. We would expect the successful applicant to have the following: * A Bachelor's degree in a scientific/health related subject. * A sound understanding of pharmaceutical manufacturing practices, process validation, pharmaceutical regulatory system and regulatory compliance with >5 years experience in this field.. * An understanding of the pharmaceutical regulatory system. * A sound understanding of regulatory compliance. * Experience in line management and working cross-functionally. * Experience in establishing processes and systems and management of master production records. * A sound understanding of cGMP. * A problem solver who can work independently, take initiative and complete tasks to deadlines. * Highly collaborative with cross-functional teams in order to ensure business objectives are met. * Strong IT skills including MS Word, Excel, PowerPoint, Project and Outlook. * Fluency in German, Italian or French would be considered a significant advantage. Please apply with your CV and include details of your salary expectations and your notice period By applying for this role, your details will be sent to Ortolan People, who are acting as consultants for the hiring company. Ortolan People are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.